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This document specifies definitions and general requirements for cell viability analytical methods and for reporting cell viability. It provides general considerations for selecting and establishing fit-for-purpose cell viability analytical methods. It provides requirements for establishing standard operating procedures for cell viability analytical methods. It also provides considerations for managing sources of variability for cell viability measurements during pre-analytical, analytical, and post-analytical phases. This document is applicable to cells in suspension, cells adhered to a substrate, and cells in complex matrices. This document is primarily applicable to cell viability measurements of nucleated mammalian cells.